U.S. patent number 8,721,627 [Application Number 12/841,959] was granted by the patent office on 2014-05-13 for needleless valve infection prevention and pre-opening device.
This patent grant is currently assigned to CareFusion 303, Inc.. The grantee listed for this patent is Robert S. Alpert. Invention is credited to Robert S. Alpert.
United States Patent |
8,721,627 |
Alpert |
May 13, 2014 |
Needleless valve infection prevention and pre-opening device
Abstract
A disinfecting and pre-opening device is disclosed for use with
a female needleless connector. The disinfecting and pre-opening
device includes a housing comprising a chamber having a distal
opening and configured to fit over the female needleless connector,
and an elongated finger attached to the housing and disposed within
the chamber such that the elongated finger opens the fluid path
through the female needleless connector when the distal opening of
the disinfecting and pre-opening device is placed proximally
adjacent to the septum and the disinfecting and pre-opening device
is advanced in the distal direction.
Inventors: |
Alpert; Robert S. (Escondido,
CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Alpert; Robert S. |
Escondido |
CA |
US |
|
|
Assignee: |
CareFusion 303, Inc. (San
Diego, CA)
|
Family
ID: |
45494194 |
Appl.
No.: |
12/841,959 |
Filed: |
July 22, 2010 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20120022469 A1 |
Jan 26, 2012 |
|
Current U.S.
Class: |
604/533; 604/91;
604/265 |
Current CPC
Class: |
A61M
39/16 (20130101); A61M 39/165 (20130101); A61M
39/18 (20130101); A61M 39/20 (20130101); A61M
39/162 (20130101); A61M 2205/0205 (20130101); A61M
2039/1072 (20130101); A61M 2039/1077 (20130101) |
Current International
Class: |
A61M
25/16 (20060101); A61M 39/10 (20060101); A61M
25/00 (20060101); A61M 25/18 (20060101); A61M
5/32 (20060101); A61M 39/00 (20060101); A61M
37/00 (20060101) |
Field of
Search: |
;604/255-256,267,533,89,86,91 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Lucchesi; Nicholas
Assistant Examiner: Eisenberg; Rebecca E
Attorney, Agent or Firm: McDermott Will & Emery LLP
Claims
What is claimed is:
1. A device for use with a female needleless connector having a
proximal end, comprising: a housing comprising a chamber having a
proximal wall, a continuous side wall coupled to the proximal wall,
and a distal opening that is configured to fit over the proximal
end of the female needleless connector; a fluid-absorbing matrix
disposed within the chamber; a disinfectant disposed within the
fluid-absorbing matrix; a solid elongated finger attached to the
proximal wall of the housing and disposed within the chamber such
that the elongated finger opens the fluid path through the female
needleless connector when the distal opening of the housing is
placed adjacent to the proximal end of the female needleless
connector and the device is advanced in the distal direction; and a
lining on a portion of an internal surface of the chamber and
configured to create a removable interference fit with an external
surface of the female needleless connector.
2. The device of claim 1, wherein: the female needleless connector
comprises a septum located at the proximal end of the female
needleless connector, the septum having a pre-cut slit; and the
elongated finger substantially penetrates the septum through the
pre-cut slit when the distal opening of the device is placed
proximally adjacent to the septum and the device is advanced in the
distal direction.
3. The device of claim 1, wherein: the female needleless connector
comprises a piston that is surrounded by a housing; and the
elongated finger displaces the piston relative to the housing when
the distal opening of the device is placed adjacent to the proximal
end of the female needleless connector and the device is advanced
in the distal direction.
4. The device of claim 1, further comprising a vapor barrier lid
removably sealed across the distal opening of the chamber.
5. The device of claim 4, wherein the portion of the chamber sealed
by the vapor barrier lid is sterile.
6. The device of claim 1, wherein the matrix is disposed on a
proximal wall of the chamber.
7. The device of claim 6, wherein the matrix is further disposed on
a portion of a sidewall adjacent to the proximal wall of the
chamber.
8. The device of claim 6, wherein the matrix is further disposed on
a portion of the elongated finger.
9. The device of claim 1, wherein the housing further comprises a
second chamber and a neck that is sized and configured to removably
couple to a male needleless connector.
10. The device of claim 1, wherein the female needleless connector
comprises a housing and an external thread formed on an external
circumferential surface of the housing, and the device further
comprising a thread formed on an internal surface of the chamber
and configured to engage the external thread of the female
needleless connector.
11. The device of claim 1, wherein the female needleless connector
is a Luer fitting.
12. A device for use with a female needleless connector having a
proximal end, comprising: a housing comprising (i) a first chamber
having a proximal wall, a continuous side wall coupled to the
proximal wall, and a distal opening that is configured to fit over
the proximal end of the female needleless connector, and (ii) a
second chamber and a neck that is sized and configured to removably
couple to a male needleless connector; a fluid-absorbing matrix
disposed within the first chamber; a disinfectant disposed within
the fluid-absorbing matrix; a solid elongated finger attached to
the proximal wall of the housing and disposed within the first
chamber such that the elongated finger opens the fluid path through
the female needleless connector when the distal opening of the
housing is placed adjacent to the proximal end of the female
needleless connector and the device is advanced in the distal
direction.
13. The device of claim 12, wherein: the female needleless
connector comprises a septum located at the proximal end of the
female needleless connector, the septum having a pre-cut slit; and
the elongated finger substantially penetrates the septum through
the pre-cut slit when the distal opening of the device is placed
proximally adjacent to the septum and the device is advanced in the
distal direction.
14. The device of claim 12, wherein: the female needleless
connector comprises a piston that is surrounded by a housing; and
the elongated finger displaces the piston relative to the housing
when the distal opening of the device is placed adjacent to the
proximal end of the female needleless connector and the device is
advanced in the distal direction.
15. The device of claim 12, further comprising a vapor barrier lid
removably sealed across the distal opening of the chamber.
16. The device of claim 15, wherein the portion of the chamber
sealed by the vapor barrier lid is sterile.
17. The device of claim 12, wherein the matrix is disposed on a
proximal wall of the chamber.
18. The device of claim 17, wherein the matrix is further disposed
on a portion of a sidewall adjacent to the proximal wall of the
chamber.
19. The device of claim 18, wherein the matrix is further disposed
on a portion of the elongated finger.
20. The device of claim 12, wherein the female needleless connector
comprises a housing and an external thread formed on an external
circumferential surface of the housing, and the device further
comprising a thread formed on an internal surface of the chamber
and configured to engage the external thread of the female
needleless connector.
21. The device of claim 12, further comprising a lining on a
portion of an internal surface of the chamber and configured to
create a removable interference fit with an external surface of the
female needleless connector.
22. The device of claim 12, wherein the female needleless connector
is a Luer fitting.
Description
FIELD
The present disclosure generally relates to needleless connectors
in fluid systems and, in particular, to infection prevention and
preparation of needleless connectors in intravenous infusion
systems.
BACKGROUND
Many healthcare facilities have converted to needleless intravenous
(IV) infusion systems to reduce the risk of injury to the
healthcare provider. The infusion sets that are used as part of a
needleless infusion system frequently have access ports so that
additional medications can be administered without disconnecting
the tubing from the IV pump or IV fluid container. One such
needleless system uses Luer fittings to connect fluid components
together, with the female Luer connector that may incorporate an
elastomeric septum having a slit or a piston. When a syringe or
other fluid container that is fitted with a male Luer connector is
mated to the female Luer connector of the access port, the male
Luer tip penetrates through the slit in the septum or displaces the
piston to establish a fluid path between the connectors.
Needleless connectors in an IV system must be sterile prior to the
mating of the two connectors to prevent bacteria or other
microorganisms from being carried by the IV fluid into the
bloodstream of the patient. While the access port is sterile when
removed from its package, it is exposed to the open air while in
use and can possibly be contaminated shortly after it is removed
from the package. It is a common protocol to sterilize the surface
of the septum of the access port by wiping the septum with a
disinfectant such as isopropyl alcohol immediately prior to mating
a male Luer connector to the access port. This requires the
healthcare provider to have alcohol wipes on hand and, if they do
not have any wipes or swabs available when they are about to
connect a fluid container to the access port, they must stop and
return to the supply cabinet to gather more alcohol wipes. This
takes up valuable time and creates a risk of this sterilization
step being skipped.
Healthcare providers occasionally experience difficulty in
connecting a male Luer fitting to a female Luer connector having a
pre-slit septum. The tip of the male Luer fitting may not entirely
penetrate the slit and the septum deforms without creating a fluid
path. In such cases, the connectors must be separated and
reconnected, which creates an opportunity for contamination of the
connector surfaces and is not clinically recommended. In some
cases, the slit will not fully open and the healthcare provider
must replace the infusion set having the failed access port, which
consumes the healthcare provider's time and may cause discomfort
for the patient as well as present additional risk of infection or
sympathetic flow.
Accordingly, there is a need for a device and method that increases
the probabilities that an exposed surface of a female Luer
connector is disinfected prior to mating connectors and that the
pre-slit septum will properly mate with a male Luer fitting.
SUMMARY
The disclosed device enables healthcare providers to sterilize the
external surface of a pre-slit septum in a female Luer connector
and pre-opens the slit to ensure that a proper fluid path is
established during the first access when a male Luer connector is
mated to the female Luer connector.
A disinfecting and pre-opening device is disclosed for use with a
female needleless connector. The disinfecting and pre-opening
device includes a housing comprising a chamber having a distal
opening and configured to fit over the female needleless connector,
and an elongated finger attached to the housing and disposed within
the chamber such that the elongated finger opens the fluid path
through the female needleless connector when the distal opening of
the disinfecting and pre-opening device is placed proximally
adjacent to the septum and the disinfecting and pre-opening device
is advanced in the distal direction.
In another embodiment, a disinfecting and pre-opening system for
use with a female needleless connector is disclosed. The
disinfecting and pre-opening system includes a fluid delivery
appliance having a male needleless connector; and a disinfecting
and pre-opening device removably coupled to the male needleless
connector of the fluid delivery appliance. The disinfecting and
pre-opening device includes a housing comprising a chamber
configured to fit over the female needleless connector, a
disinfectant disposed within the chamber, and an elongated finger
attached to the housing and disposed within the chamber such that
the elongated finger opens the fluid path through the female
needleless connector when the distal opening of the disinfecting
and pre-opening device is placed proximally adjacent to the septum
and the disinfecting and pre-opening device is advanced in the
distal direction.
In another embodiment, a method of disinfecting and pre-opening a
female needleless connector, and connecting a fluid delivery
appliance having a male needleless connector to the female
needleless connector is disclosed. The method includes the steps of
removing a portion of a lid that is removably sealed across a
distal opening of a chamber of a disinfecting and pre-opening
device, wherein the chamber is configured to fit over the female
needleless connector and the chamber contains a disinfectant and a
finger, placing the distal opening of the disinfecting and
pre-opening device proximally adjacent to the septum of the female
needleless connector and advancing the disinfecting and pre opening
device in the distal direction until the disinfectant contacts the
surface of the septum and the finger opens the fluid path through
the female needleless connector, removing the disinfecting and
pre-opening device from the female needleless connector, and mating
the male needleless connector of the fluid delivery appliance to
the female needleless connector.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings, which are included to provide further
understanding and are incorporated in and constitute a part of this
specification, illustrate disclosed embodiments and together with
the description serve to explain the principles of the disclosed
embodiments. In the drawings:
FIG. 1 illustrates an example prior art IV infusion system.
FIG. 2 is an enlarged view of a prior art female Luer access port
of FIG. 1 having a pre-slit septum.
FIGS. 3A-3B illustrate a prior art process of connecting a male
Luer connector to a female Luer connector having a pre-slit
septum.
FIG. 3C illustrates one possible failure mode in a prior art
process of connecting a male Luer connector to a female Luer
connector having a pre-slit septum.
FIGS. 3D-3E illustrate a prior art process of connecting a male
Luer connector to a female Luer connector having a piston with a
pre-cut slit.
FIG. 3F illustrates one possible failure mode in a prior art
process of connecting a male Luer connector to a female Luer
connector having a piston with a pre-cut slit.
FIGS. 4A-4D illustrate a disinfecting and pre-opening device
according to certain embodiments of the present disclosure.
FIGS. 5A-5D illustrate a disinfecting and pre-opening device
according to certain other embodiments of the present
disclosure.
FIG. 6 illustrates a disinfecting and pre-opening device configured
as a separate item according to certain aspects of the present
disclosure.
FIG. 7 illustrates a disinfecting and pre-opening device configured
to incorporate a Luer cap according to certain embodiments of the
present disclosure.
FIGS. 8A-8D depict an example sequence of use of a disinfecting and
pre-opening device according to certain embodiments of the present
disclosure.
FIG. 9 is a flow chart that illustrates an exemplary method of
using a disinfecting and pre-opening device according to certain
embodiments of the present disclosure.
DETAILED DESCRIPTION
Bloodstream infections acquired while undergoing medical treatment
present a serious risk to patients. The connectors in an infusion
system that are exposed to the open air for a period of time prior
to a connection being made from a fluid source are a potential
source of infection, as any bacteria that have accumulated on the
surface of the connector may be carried directly into the blood
stream by the fluid passing through the connector. While it is a
common protocol to sterilize the external surface of the connector
prior with an alcohol wipe prior to connecting a fluid source, this
step may be ineffective if performed incorrectly or may be skipped
altogether in some circumstances. One approach to ensuring that a
connector is sterilized prior to use is to provide a convenient
device that enables the healthcare provider to easily complete an
effective sterilization.
Failure to be able to mate a male Luer fitting to a female Luer
access port having a pre-slit septum that is part of an IV set may
require either disconnection and reconnection of the connector
fittings or possibly replacement of the entire IV set, both of
which present an additional risk of infection to the patient. The
causes of a pre-slit septum failing to accept a male Luer fitting
may include cross-linking of elastomeric components, such as the
two sides of a slit in a elastomeric septum or between a piston and
the surrounding housing, during the sterilization process during
manufacture, failure of the factory-applied lubricant to
satisfactorily penetrate the slit of the septum or between the
piston and housing, and roughness of the surface of the male Luer
tip of the mating connector. One approach to eliminating these
sources of failure is to pre-open the fluid path of the female
needleless connector during disinfection and prior to connecting a
fluid delivery appliance such as a syringe or IV tubing connected
to an IV fluid bag. This breaks any cross-link bonds between
portions of the female needleless connector and carries the
lubricant that is on the surface down into the slit or between the
piston and housing.
Certain exemplary embodiments of the present disclosure include a
device that disinfects and pre-opens a female needleless connector.
The device may be provided as a separate item or as an accessory
that can be attached to a male Luer fitting of a fluid delivery
appliance.
In the following detailed description, numerous specific details
are set forth to provide a full understanding of the present
disclosure. It will be apparent, however, to one ordinarily skilled
in the art that embodiments of the present disclosure may be
practiced without some of the specific details. In other instances,
well-known structures and techniques have not been shown in detail
so as not to obscure the disclosure.
FIG. 1 illustrates an example prior art IV infusion system 12. The
infusion system 12 incorporates a flexible IV bag 14 connected
through IV set 18, which includes the lines and fittings within the
dashed line, to an infusion pump 16 and then to a patient 10. The
fluid in the IV bag 14 may be a saline solution or a solution
containing one or more medications. If an additional medication
must be administered, such as a medication to alleviate pain, it is
undesirable to either disconnect any portion of the current IV set
18 or to start a new infusion line as both present an additional
risk of infection. The example infusion set 18 includes an access
port 20 having a needleless connector so that the additional
medication may be administered through the existing IV set 18
without disconnecting any portion of the IV set 18.
FIG. 2 is an enlarged view of a prior art female Luer access port
20 of FIG. 1 having a pre-slit septum. The access port 20 has a
housing 21 with external threads 22 so that a male Luer fitting
(not shown) may be securely and removably connected to the access
port 20. The septum 24 is, in this example, an elastomeric plug
that is mounted flush with the external surface at one end of the
access port 20 to eliminate features that are difficult to
sterilize. The septum 24 has a central slit 26 through the
thickness of the septum 24. The slit 26 is normally closed and
fluid-tight when not connected to another Luer connector. Other
configurations of access slits, such as an "X" shaped cross-cut, as
well as other types of needleless connectors incorporating other
types of seals, such as pistons, are also used in practice.
FIGS. 3A and 3B are cross-sectional views depicting a male Luer
connector 30 and a female Luer connector 40 before and after making
a needleless Luer connection, respectively. In the illustrated
example, the male Luer connector 30 includes a housing 34 having a
first Luer screw thread 36 formed therein. The male Luer connector
30 further includes a male Luer tip 32 having a cannula 38. In the
illustrated example, the male Luer connector 30 is a part of a
syringe 100, but in other embodiments, the male Luer connector may
be connected to a fluid source (e.g., an IV bag), IV tubing, or
other fluid delivery appliance. The female Luer connector 40 has an
elastomeric septum 44 with a slit 46, shown as a line through the
thickness of septum 44 in this cross-section view. The housing of
connector 40 incorporates threads 42 that will be engaged by
threaded sleeve 34 of connector 30. FIG. 3B illustrates the
configuration of a successfully mated pair of Luer connectors 30
and 40, wherein the male Luer tip 32 has penetrated through slit 46
and the threaded sleeve 34 is engaged with the threads 42 of the
female Luer connector. In this configuration, there is a fluid path
from connector 30 to connector 40 through the male Luer tip 32.
FIG. 3C illustrates one possible failure mode in connecting a male
Luer connector 30 to a female Luer connector 40. The male Luer tip
32 has not penetrated slit 46 and there is no fluid path from
connector 30 to connector 40. This failure may be due to the
elastomeric material of septum 44 having cross-linked across slit
46 during the sterilization process during manufacture and the
blunt shape of male Luer tip 32 is not effective in breaking this
cross-linked bond. Another possible cause of this failure may be
that the material of male Luer tip 32 is not sliding when in
contact with the surface of septum 44 due to a lack of lubricant or
the roughness of the male Luer tip 32.
FIGS. 3D-3E illustrate a prior art process of connecting a male
Luer connector 30 to a female Luer connector 90 having a piston 47
with a pre-cut slit 46. FIG. 3D illustrates a portion of the piston
47 which has a flat upper surface that is flush with the end of
body 41 of FIG. 3A and a collapsible body within the female Luer
connector 90. FIG. 3E illustrates the configuration of a
successfully mated pair of Luer connectors 30 and 90, wherein the
male Luer tip 32 has pushed the piston 47 into the body of Luer
connector 90, whereupon slit 46 opens, and the threaded sleeve 34
is engaged with the threads 42 of the female Luer connector. In
this configuration, there is a fluid path from connector 30 to
connector 90 through the male Luer tip 32 and slit 46.
In other configurations of female Luer connectors having pistons,
the piston may not have a slit 46 and may form a fluid path by
deformation of the piston 47 that opens a fluid path between the
side wall of male Luer tip 32 and piston 47. In other
configurations, the surface of piston 47 may be shaped so as to
provide gaps between male Luer tip 32 and the surface of piston 47
over a portion of the circumference of male Luer tip 32.
FIG. 3F illustrates one possible failure mode in a prior art
process of connecting a male Luer connector to a female Luer
connector 90 having a piston 47 with a pre-cut slit 46. In this
example, piston 47 has bonded to the housing 41, preventing the
piston from moving down into the wider region 45 where slit 46
opens. Slit 46 may also be cross-linked, further obstructing the
flow path through the female Luer connector 90.
FIGS. 4A-4D illustrate a disinfecting and pre-opening device 50
according to certain embodiments of the present disclosure. As
shown in FIG. 4A, device 50 is a separate item that is applied to
the female Luer connector 40 prior to mating the male Luer
connector 30 of FIG. 3A. The disinfecting and pre-opening device 50
comprises a housing 52 having a chamber 53 of a diameter sufficient
to encompass the width of the female Luer connector 40. The chamber
53 is formed from a circumferential sidewall 55 and a proximal wall
57. Threads 54 are formed on the inner wall of circumferential
sidewall 55 and are of the proper size and shape to engage the
threads 42 of the female Luer connector 40. Within the chamber 53
is a matrix 56 that is configured to retain a quantity of a
disinfectant fluid such as, for example and without limitation,
isopropyl alcohol or chlorhexadine. The matrix 56 can be any
fluid-absorbing material such as, for example and without
limitation, polyester, polyvinyl acetate, polyurethane, or cotton,
and may be formed into a woven or nonwoven pad or a foam. In
certain embodiments, the matrix 56 is at least partially attached
(e.g., glued) to an inside surface of the chamber 53 to prevent
movement of the matrix 56 during use. Device 50 also incorporates a
central finger 58 sized such that the tip will fully penetrate the
septum of most female Luer connectors. In this example, finger 58
has a rounded tip and a tapered shaft and a height that is less
than the height of housing 52 such that finger 58 will not contact
a surface placed across the distal opening of housing 52 thereby
avoiding contamination. The female Luer connector 40 has a septum
44 mounted to the proximal end of body 41, septum 44 having a
proximal surface 48 and a slit 46, shown in this view as dividing
the septum 44 into two pieces although septum 44 is a single
element when viewed in perpendicular directions. Surface 48 may
have a coating of lubricant (not shown) that was applied at the
time of manufacture. Threads 42 are formed on the external wall of
body 41 and conform, in this example, to the generally accepted
Luer dimensions.
FIG. 4B illustrates the position of device 50 after it has been
mated with female Luer connector 40 and rotated until the matrix 56
is seated against the surface 48 of septum 44. Contact with or
compression of matrix 56 may release a portion of the liquid
disinfectant to wet the surface 48 as well as the portions of the
body 41 adjacent to surface 48. At the same time, finger 58 has
penetrated slit 46, carrying lubricant from surface 48 into slit
46. Additionally, disinfectant released from matrix 56 may
infiltrate the slit 46 along the side of finger 58. The rotation of
the device 50 as the matrix 56 comes into contact with surface 48
may additionally provide a scrubbing action that may assist in the
cleaning and disinfection of surface 48.
FIG. 4C illustrates the position of device 50 after it has been
mated with female Luer connector 90 and rotated until the matrix 56
is seated against the surface 48 of piston 47. Contact with or
compression of matrix 56 may release a portion of the liquid
disinfectant to wet the surface 48 as well as the portions of the
body 41 adjacent to surface 48. At the same time, finger 58 has
displaced piston 47, allowing lubricant to coat the surface of body
41 formerly in contact with the side of piston 47, and penetrated
slit 46, carrying lubricant from surface 48 into slit 46.
Additionally, disinfectant released from matrix 56 may infiltrate
the slit 46 along the side of finger 58.
FIG. 4D illustrates the position of device 50 after it has been
mated with a female Luer connector 91 that comprises a piston 49
that does not have a slit, wherein the flow path through the female
Luer connector 91 is between housing 41 and the outside of piston
49. Finger 58 has displaced piston 49 to break any cross-links
between the piston 49 and the housing 41 and open the fluid path
through female Luer connector 91. Disinfectant released from matrix
56 may flow down and onto the surface 51 of piston 49, or
disinfection of surface 51 may be performed as a separate
operation.
FIGS. 5A-5D illustrate configurations of a disinfecting and
pre-opening device according to certain other embodiments of the
present disclosure. FIG. 5A illustrates a device 50 wherein housing
52 has a smooth interior wall 60 such that the device is applied to
female Luer connector 40 of FIG. 4B by sliding rather than screwing
device 50 onto the threads 42 of female Luer connector 40. FIG. 5B
shows a device 50 having a lining 62 of an elastomeric material
located on the wall of chamber 53 and sized such that the sleeve 62
contacts the threads 42 or external wall of body 41 such that the
device 50 is removably retained on female Luer connector 40. Lining
62 may be a coating on the wall of chamber 53 or a separate sleeve
that is inserted into the chamber 53. FIG. 4C discloses a
configuration wherein the matrix 56 is formed such that a portion
64 of matrix 56 coats a portion of the inner wall of chamber 53 and
a second portion 65 coats a portion of finger 58. In this example,
matrix 56 does not cover the tip of finger 58 although other
configurations may cover the entire surface of finger 58. FIG. 5D
illustrates a configuration wherein the matrix 56 has a portion 66
that coats a portion of the smooth inner wall of chamber 53 and a
portion 68 that coats a portion of finger 58 wherein finger 58 is
undercut where portion 68 terminates.
FIG. 6 illustrates a disinfecting and pre-opening device configured
as a separate item according to certain embodiments of the present
disclosure. Certain features depicted in FIG. 6 can be employed
with any of the embodiments of FIGS. 4a-4B and FIGS. 5A-5D. In this
example, the circumferential sidewall 55 is a tapered cylinder. In
certain embodiments, the circumferential sidewall 55 may be
configured as a square, a hexagon, or other shape with or without a
taper. There is a proximal wall (not visible in this view) that is
attached and sealed to the circumferential side wall 55 around the
entire circumference of the circumferential side wall 55 along the
proximal edge of the circumferential side wall 55, forming a sealed
cup-like structure. The housing 52 may be molded in a single piece
from a plastic, such as polypropylene or styrene, or other suitable
material. Chamber 53 contains a disinfectant that may be carried in
a liquid-absorbing matrix (not shown). A lid 70 is sealed across
the distal opening of chamber 53. Lid 70 comprises a low
permeability material such as aluminum foil and is sealed to
housing 52 to form a vapor and liquid barrier to prevent leakage or
evaporation of the disinfectant liquid that is contained in chamber
53. The lid 70 is further configured to overhang the edge of
housing 52 or, alternately, have a tab that projects beyond the rim
of housing 52 such that the lid 70 can easily be peeled off the
housing 52. Lid 70 may also have a second tab or flap (not shown)
that is folded over and bonded to the external surface of the
circumferential side wall 55 such that the lid 70 is not detached
from the housing 52 after the lid 70 is peeled away from the distal
edge of the circumferential side wall 55, avoiding the creation of
a separate piece of trash. It shall be appreciated by those skilled
in the art in view of the subject disclosure that a sealing
mechanism other than the peelable lid, such as a snap-fit cover,
may be employed without departing from the scope of the subject
disclosure. An elongated finger 58 is located within chamber 53
and, in this example, having a height such that the tip of
elongated finger is within the chamber 53 so that lid 70 is not in
contact with finger 58.
FIG. 7 illustrates a disinfecting and pre-opening device configured
to incorporate a Luer cap according to certain aspects of the
present disclosure. In this example, the housing 52 further
includes a second chamber 74 and a neck 76 sized and configured to
engage the threads 34 of male Luer connector 30. In certain
embodiments, device 50 is attached to the male Luer connector 30 as
delivered to the user and is therefore assured of being at hand at
the time of use. In certain embodiments, device 50 incorporates a
sealing layer 78 which seals against Luer tip 32. This
configuration is advantageous in that it protects the interior of
male Luer connector 30 from contamination prior to use. In certain
embodiments, sealing layer 78 may comprise an absorbent material
and a disinfectant. Alternate configurations adapted for connection
to other types of connectors in this same manner will be apparent
to those of ordinary skill in the art without departing from the
scope of the subject disclosure.
FIGS. 8A-8D depict an example sequence of use of a disinfecting and
pre-opening device according to certain aspects of the present
disclosure. FIG. 8A illustrates a syringe 80 having a device 50,
including a peelable lid 70, attached to the male Luer connector
30. The device 50 is the embodiment depicted in FIG. 7. This is
representative of how a syringe may be delivered and stocked in a
care unit. Other types of fluid containers, infusion sets, tubing,
etc. may be substituted in place of the syringe. FIG. 8B
illustrates the first step of entirely removing the lid 70 at the
time to connect syringe 30 to a female Luer connector 40. An
alternate process would be to only peel back lid 70 without
detaching lid 70 from device 50. FIG. 8C illustrates device 50
connected to female Luer connector 30 with matrix 56 in contact
with septum 44 and finger 58 penetrating through slit 46. FIG. 8D
shows the final step wherein the device 50 has been detached from
female Luer connector 40 and then removed from syringe 80 and
discarded. The male Luer connector 30 of syringe 80 has now been
connected to female Luer connector 30 with a fluid path established
from syringe 80 to the container attached to female Luer connector
40.
FIG. 9 is a flow chart that illustrates an example method of using
a disinfecting and pre-opening device according to certain aspects
of the present disclosure. This example is drawn to a scenario
having a nurse who wishes to administer a medical fluid to a
patient using a syringe to introduce the fluid to an intravenous
set having an access port having a needleless female Luer connector
having a pre-slit septum. Starting at step 100, the nurse selects a
syringe having a male Luer connector with an attached disinfecting
and pre-opening device of the type illustrated in FIG. 8A and, in
step 105, fills the syringe with the medical fluid. Alternately,
the nurse could fill a syringe and collect a separate disinfecting
and pre-opening device. In step 110, the nurse removes the lid from
the disinfecting and pre-opening device, exposing the
disinfectant-filled matrix and the pre-opening finger. In step 115,
the nurse attaches the disinfecting and pre-opening device to the
female Luer connector of, in this example, the access port of the
IV set and tightens the disinfecting and pre-opening device onto
the female Luer connector until the disinfectant-filled matrix
comes into contact with the septum and the finger penetrates the
slit. The nurse then, in step 120, detaches the disinfecting and
pre-opening device from the female Luer connector and also removes
the disinfecting and pre-opening device from the syringe and
discards the disinfecting and pre-opening device. The nurse then
attached the male Luer connector of the syringe to the female Luer
connector of the access port as described in step 125. This
completes the process, indicated by step 130, and the system is
configured to administer the medical fluid to the patient.
In summary, a disinfecting and pre-opening device has been
disclosed that is suitable for use with female Luer connectors
having a pre-slit septum. The device applies a disinfectant to the
exposed surface of a female needleless connector and pre-opens the
slit in the septum. The application of a disinfectant reduces the
chance of a bacteria or other microbe being carried by the fluid
passing through the female Luer connector into the bloodstream of a
patient. The pre-opening of the slit reduces the chance of a male
Luer connector not properly mating with the female Luer connector
due to cross-linking of the septum across the slit or a lack of
lubrication within the slit. As resolution of a problem in mating
Luer connectors may require replacement of the entire IV set, which
introduces a risk of infection, both the application of
disinfectant and the pre-opening of the slit increase the safety of
the patient by reducing the chance of infection. Additionally, the
disinfecting and pre-opening device is in a convenient sealed
package that can be carried by the nurse or provided as an
attachment to the syringe or other item having a male Luer
connector, reducing the chance that the nurse will not have the
proper supplies at hand to sterilize the female Luer connector.
The previous description is provided to enable any person skilled
in the art to practice the various aspects described herein. While
the foregoing has described what are considered to be the best mode
and/or other examples, it is understood that various modifications
to these aspects will be readily apparent to those skilled in the
art, and the generic principles defined herein may be applied to
other aspects. Thus, the claims are not intended to be limited to
the aspects shown herein, but is to be accorded the full scope
consistent with the language claims, wherein reference to an
element in the singular is not intended to mean "one and only one"
unless specifically so stated, but rather "one or more." Unless
specifically stated otherwise, the term "some" refers to one or
more. Pronouns in the masculine (e.g., his) include the feminine
and neuter gender (e.g., her and its) and vice versa. Headings and
subheadings, if any, are used for convenience only and do not limit
the invention.
It is understood that the specific order or hierarchy of steps in
the processes disclosed is an illustration of exemplary approaches.
Based upon design preferences, it is understood that the specific
order or hierarchy of steps in the processes may be rearranged.
Some of the steps may be performed simultaneously. The accompanying
method claims present elements of the various steps in a sample
order, and are not meant to be limited to the specific order or
hierarchy presented.
The term "slit" is used to indicate a separation of a flexible
barrier that allows an elongated element to pass through the
flexible barrier by widening the separation generally without
further cutting or puncture of the flexible barrier. In some cases,
the slit may not traverse the entire thickness of the flexible
barrier, with the remaining portion of the thickness left intact to
present a complete seal prior to the first insertion of an
elongated element. The two sides of the slit may be in intimate
contact and form a liquid-tight seal when the slit is in an
undeformed condition. The slit may be a single linear cut, in plan
view, or may have a more complex form such as two cuts in the form
of an "X" or a plurality of cuts on a common center at angles to
each other.
Terms such as "top," "bottom," "front," "rear" and the like as used
in this disclosure should be understood as referring to an
arbitrary frame of reference, rather than to the ordinary
gravitational frame of reference. Thus, a top surface, a bottom
surface, a front surface, and a rear surface may extend upwardly,
downwardly, diagonally, or horizontally in a gravitational frame of
reference.
A phrase such as an "aspect" does not imply that such aspect is
essential to the subject technology or that such aspect applies to
all configurations of the subject technology. A disclosure relating
to an aspect may apply to all configurations, or one or more
configurations. A phrase such as an aspect may refer to one or more
aspects and vice versa. A phrase such as an "embodiment" does not
imply that such embodiment is essential to the subject technology
or that such embodiment applies to all configurations of the
subject technology. A disclosure relating to an embodiment may
apply to all embodiments, or one or more embodiments. A phrase such
an embodiment may refer to one or more embodiments and vice
versa.
The word "exemplary" is used herein to mean "serving as an example
or illustration." Any aspect or design described herein as
"exemplary" is not necessarily to be construed as preferred or
advantageous over other aspects or designs.
All structural and functional equivalents to the elements of the
various aspects described throughout this disclosure that are known
or later come to be known to those of ordinary skill in the art are
expressly incorporated herein by reference and are intended to be
encompassed by the claims. Moreover, nothing disclosed herein is
intended to be dedicated to the public regardless of whether such
disclosure is explicitly recited in the claims. No claim element is
to be construed under the provisions of 35 U.S.C. .sctn.112, sixth
paragraph, unless the element is expressly recited using the phrase
"means for" or, in the case of a method claim, the element is
recited using the phrase "step for." Furthermore, to the extent
that the term "include," "have," or the like is used in the
description or the claims, such term is intended to be inclusive in
a manner similar to the term "comprise" as "comprise" is
interpreted when employed as a transitional word in a claim.
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